Endoscopic plication devices and methods

ABSTRACT

Endoscopic plicators are passed transorally into the stomach and used to plicate stomach tissue by engaging tissue from inside of the stomach and drawing it inwardly. The tissue is drawn inwardly into a vacuum chamber, causing sections of serosal tissue on the exterior of the stomach to be positioned facing one another. The plicators allow the opposed sections of tissue to be moved into contact with one another, and preferably deliver sutures, staples or other means for maintaining contact between the tissue sections at least until serosal bonds form between them. Each of these steps may be performed wholly from the inside of the stomach and thus can eliminate the need for any surgical or laparscopic intervention. After one or more plications is formed, medical devices may be coupled to the plication(s) for retention within the stomach.

PRIORITY

This application claims the benefit of U.S. Provisional Application No.60/723,160, filed Oct. 3, 2005; U.S. Provisional Application No.60/754,417, filed Dec. 28, 2005; and U.S. Provisional Application No.60/825,534, filed Sep. 13, 2006.

FIELD OF THE INVENTION

The present invention relates generally to the field of systems andmethods for performing endoscopic surgery, and specifically to systemsand methods for endoscopic plication of tissue within body cavities.

BACKGROUND OF THE INVENTION

An anatomical view of a human stomach S and associated features is shownin FIG. 1A. The esophagus E delivers food from the mouth to the proximalportion of the stomach S. The z-line or gastro-esophageal junction Z isthe irregularly-shaped border between the thin tissue of the esophagusand the thicker tissue of the stomach wall. The gastro-esophagealjunction region G is the region encompassing the distal portion of theesophagus E, the z-line, and the proximal portion of the stomach S.

Stomach S includes a fundus F at its proximal end and an antrum A at itsdistal end. Antrum A feeds into the pylorus P which attaches to theduodenum D, the proximal region of the small intestine. Within thepylorus P is a sphincter that prevents backflow of food from theduodenum D into the stomach. The middle region of the small intestine,positioned distally of the duodenum D, is the jejunum J.

FIG. 1B illustrates the tissue layers forming the stomach wall. Theoutermost layer is the serosal layer or “serosa” S and the innermostlayer, lining the stomach interior, is the mucosal layer or “mucosa”MUC. The submucosa SM and the multi-layer muscularis M lie between themucosa and the serosa.

Several prior applications sharing inventors with the presentapplication, including International Application No. WO 2005/037152having an international filing date of Oct. 8, 2004 and U.S. applicationSer. No. 11/439,461, filed May 23, 2006 (both incorporated herein byreference) describe methods according to which medical implants arecoupled to tissue structures formed within the stomach. According tothese applications, devices for inducing weight loss (e.g. byrestricting and/or obstructing flow of food into the stomach, and/or byoccupying a portion of the stomach volume) may be coupled to tissuetunnels or plications P (FIG. 2) formed from stomach tissue.

For example, U.S. application Ser. No. 11/439,461 (incorporated hereinby reference in its entirety), describes a restrictive and/orobstructive implant system for inducing weight loss. In one embodiment,flexible loops 2 (FIG. 3) are coupled to tissue plications P (FIG. 2)formed in the gastroesophageal junction region of the stomach. Animplant, such as a flow restrictive and/or obstructive implant 4 (FIG.4), is passed through the loops 2 and thus retained in the stomach asshown in FIG. 5.

In other instances, tissue plications may themselves be sufficient toprovide the necessary treatment. For example, the plications may be usedto reduce stomach volume or form a flow restriction within the stomach.

Other types of implants may be coupled to such plications or othertissue structures for a variety of purposes. These implants include, butare not limited to prosthetic valves for the treatment ofgastro-esophageal reflux disease, gastric stimulators, pH monitors anddrug eluting devices that release drugs, biologics or cells into thestomach or elsewhere in the GI tract. Such drug eluting devices mightinclude those which release leptin (a hormone which creates feelings ofsatiety), Ghrelin (a hormone which creates feelings of hunger),octreotide (which reduces Ghrelin levels and thus reduces hunger),Insulin, chemotherapeutic agents, natural biologics (e.g. growth factor,cytokines) which aid in post surgery trauma, ulcers, lacerations etc.Still other implants might be of a type which might provide a platformto which specific cell types can adhere, grow and providebiologically-active gene products to the GI tract, and/or a platform forradiation sources that can provide a local source of radiation fortherapeutic purposes, or provide a platform whereby diagnostic ligandsare immobilized and used to sample the GI tract for evidence of specificnormal or pathological conditions, or provide an anchor point forimaging the GI tract via cameras and other image collecting devices.

The prior applications listed above, address the desirability of formingtissue plications, pockets or tunnels in a way that regions of serosaltissue (i.e. the tissue on the exterior surface of the stomach) areretained in contact with one another. Over time, adhesions formedbetween the opposed serosal layers create strong bonds that canfacilitate retention of the plication/pocket/tissue over extendeddurations, despite the forces imparted on them by stomach movement andimplanted devices. More durable plications can be created by placing anyof a number of materials and/or substances (i.e. injectable sclerosingagents) between the serosal surfaces prior to plicating the serosalsurfaces together. One example of material suitable for this purpose ispolypropolyene mesh, commonly used for hernia repair, which wheninserted in the plication fold provides a durable anchoring positionwithin the GI tract.

Regardless of the application for which a plication is being formed, itis highly desirable to form that plication using steps carried out fromwithin the stomach using instruments passed down the esophagus, ratherthan using more invasive surgical or laparoscopic methods. The presentapplication describes endoscopic plicators which may be passedtransorally into the stomach and used to form serosal-to-serosalplications in a stomach wall.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a schematic illustration of a human stomach and a portion ofthe small intestine.

FIG. 1B is a cross-sectional perspective view of a portion of a stomachwall, illustrating the layers of tissue forming the wall.

FIG. 2 schematically illustrates a serosal tissue plication formed instomach tissue.

FIG. 3 schematically illustrates a pair of loops attached to serosaltissue plications, prior to the positioning of a medical implant withinthe loops.

FIG. 4 is a cross-sectional side elevation view of a satiation implant.

FIG. 5 schematically illustrates the satiation implant of FIG. 4 coupledto the loops of FIG. 3.

FIG. 6 is a perspective view of an endoscopic plication system.

FIG. 7 is a perspective view of the vacuum head of the system of FIG. 6.

FIG. 8A is a side elevation view of the cannula of the system of FIG. 6.

FIG. 8B is a perspective view of the distal end of the cannula of FIG.8A.

FIG. 9 is a cross-sectional side view of an anchor of the system of FIG.6.

FIG. 10 is a plan view of the catch of the anchor of FIG. 9.

FIG. 11A is a plan view of the spring element of the anchor of FIG. 9.

FIG. 11B is a perspective view of the spring element of FIG. 11A,showing the spring tabs in the opened position.

FIG. 12 is a perspective view of the vacuum head of FIG. 7, showing theanchor of FIG. 9 positioned within the vacuum head.

FIG. 13 is a perspective view of the anchor of FIG. 9, which includes aloop of the type shown in FIG. 3.

FIG. 14A is a perspective view of the mesh tube of the system of FIG. 6.

FIG. 14B is cross-sectional perspective view showing the mesh tube ofFIG. 14A in the compressed orientation.

FIG. 15A is a side elevation view showing the tip, cable, mesh tube, andsheath of FIG. 6 following assembly.

FIG. 15B is a side elevation view of the plicator of FIG. 6 assembledfor use.

FIG. 16A schematically illustrates introduction of the assembledplicator and an endoscope into the stomach.

FIG. 16B schematically illustrates creation of a tissue pocket using theplicator of FIG. 16A.

FIG. 17A is a perspective view of a barbed stabilizing cuff.

FIG. 17B is a perspective view similar to FIG. 16B, showing use of thebarbed stabilizing cuff of FIG. 17A to stabilize tissue within thepocket.

FIG. 18A schematically illustrates positioning of the tip element andmesh tube following their deployment.

FIG. 18B schematically illustrates the stomach exterior surfacefollowing deployment of the tip and anchor.

FIG. 19A illustrates compression of the anchor using the plicator andcable.

FIG. 19B shows the final anchor and mesh position following removal ofthe plicator and endoscope.

FIG. 20 illustrates an alternative method for compressing the anchor.

FIGS. 21A through 21C are perspective views illustrating an alternativevacuum chamber in which the vacuum chamber also forms the implantableanchor.

FIGS. 22A through 22D are a sequence of steps illustrating analternative method using a vacuum paddle that additionally functions asan implantable anchor.

FIGS. 23A through 23B and 24A through 24B are a sequence of stepsillustrating an alternative method which forms a serosal tunnel andpositions a leg of an anchor within the serosal tunnel. FIGS. 23A and23B are cross-sectional side views. FIGS. 24A and 24B are perspectiveviews taken from within the stomach.

FIG. 25A is a perspective view taken from within the stomachillustrating the serosal tunnel formed during the sequence of stepsillustrated in FIGS. 23A through 24B.

FIG. 25B is a cross-section view of the serosal tunnel and anchor shownin FIG. 25A.

FIG. 25C illustrates placement of two of the anchors of FIGS. 23A-24Bwithin a stomach.

FIGS. 26A through 26C are cross-sectional side views of a plicationsystem and a stomach wall, illustrating an alternative method in which asclerosing agent is injected into the serosal pocket prior toadvancement of the tip element.

FIGS. 27A and 27B are cross-section views illustrating a method forsealing sclerosing agent within the serosal pocket using a clamp.

FIGS. 28 and 29, in which FIG. 28 is a perspective view and FIG. 29 is across-section view of a distal end of a plication system and a portionof the stomach wall, illustrate methods for sealing sclerosing agentwithin the serosal pocket using the vacuum head.

FIGS. 30A through 30D are a sequence of side views of a stomach wallengaged by a vacuum chamber, and illustrate steps of an alternativemethod of forming a tissue plication using sclerosing agents.

FIGS. 31A and 31B illustrate alternate place holding elements for use inthe method of FIGS. 30A-30D.

FIGS. 32A and 32B illustrate the use of clamps to retain plicationsformed using the FIG. 30A-30D method during healing of the plications.

FIG. 33A is a perspective view of a serosal plication having a cutoutformed through the tissue. FIG. 33B is a cross-section view of a stomachillustrating three serosal plications of the type shown in FIG. 33A.

FIG. 34A is a cross-sectional side view of a second preferred embodimentof a plication system.

FIGS. 34B-34G are a sequence of cross-sectional side views illustratingformation of a plication of the type shown in FIG. 33A using the systemof FIG. 34A.

FIG. 35A is a cross-section side view of the plication formed inaccordance with the method of FIGS. 34A-34G.

FIG. 35B is a cross-sectional plan view taken along the plane designated35B-35B in FIG. 35A.

FIG. 36A is a perspective view of the plication head of an alternativeembodiment of a plicator, shown in the streamlined positioned fortransoral delivery to the stomach. The shroud is not shown to allowclear viewing of the underlying components.

FIG. 36B is a perspective view similar to FIG. 36A showing the plicationhead in the expanded position. The shroud is not shown to allow clearviewing of the underlying components.

FIGS. 37A through 37D are a sequence of cross-sectional perspectiveviews of the plication head of FIGS. 36A and 36B, illustrating a methodof using the plication head. The shroud is not shown to allow clearviewing of the underlying components.

FIG. 38 is a bottom plan view of the plication head of FIGS. 36A-37Cwith the shroud in place and the hinge members in the expanded position.

FIG. 39 is a front elevation view of the plication head as positioned inFIG. 38.

FIG. 40A is a cross-sectional side views of the hydraulic chamber apiston assembly used for expanding the vacuum chamber, compressingtissue, and driving the staples in the embodiment of FIGS. 36A-39.

FIG. 40B is a cross-sectional side view of the staple driver of theembodiment of FIGS. 36A-37D.

FIGS. 41A and 41B are side elevation views of a modified plication headwith the shroud not shown to permit the underlying components to beseen.

FIG. 41C is a perspective view of the plication head of FIGS. 41A and41B, with the shroud shown.

FIG. 42A is a perspective view of an expandable frame for deploying areinforcing element. FIG. 42B shows a reinforcing element on the frameof FIG. 42A.

FIGS. 43A and 43B are plan views illustrating staple patterns.

FIGS. 43C-43E are plan views illustrating interlocking staple patterns.

FIGS. 44A and 44B are plan views of reinforcing rings.

FIG. 45A is a perspective view showing the reinforcing ring of FIG. 44Bon a stapler anvil.

FIG. 45B is a plan view of the reinforcing ring of FIG. 44A on a staplecartridge.

FIGS. 46A and 46B are plan views of a tissue plication, in which FIG.46A shows the side of the plication positioned on the staple cartridgeside of the plicator, and FIG. 46B shows the side of the plicationposition on the anvil side of the plicator.

FIG. 47A is a cross-sectional top view of a stomach, illustratingmovement of cutout plications into alignment in preparation forinsertion of an implant through their cutouts.

FIG. 47B is a cross-sectional side view of a stomach, illustrating thealignment step of FIG. 47A.

FIG. 47C is a cross-sectional side view similar to FIG. 47B, with theimplant in place within the cutouts.

FIG. 48A is a cross-sectional top view of a stomach illustrating anarrangement of cutout plications.

FIG. 48B is a cross-sectional top view similar to FIG. 48A, showing thecutout plications drawn into alignment with one another.

FIG. 48C is a cross-sectional top view similar to FIG. 48B, showing animplant positioned in the aligned cutouts of the plications.

FIG. 48D is a cross-sectional side view of the stomach, illustrating theformation of a food passage in the stomach using the arrangement ofplications and the implant shown in FIG. 48C.

FIG. 49 is a perspective view of a restrictive implant having buttonsinsertable through holes formed in stomach tissue plications.

DETAILED DESCRIPTION OF THE DRAWINGS

The present application describes endoscopic plicators which may bepassed transorally into the stomach and used to plicate stomach tissueby engaging tissue from inside of the stomach and drawing it inwardly.In the disclosed embodiments, the tissue is drawn inwardly into a vacuumchamber, although tissue may be drawn inwardly using other componentsthat do not involve the use of a vacuum. When a portion the stomach wallis drawn inwardly, sections of serosal tissue on the exterior of thestomach are positioned facing one another. The disclosed plicators allowthe opposed sections of tissue to be moved into contact with oneanother, and preferably deliver sutures, staples or other means formaintaining contact between the tissue sections at least until serosalbonds form between them. Each of these steps may be performed whollyfrom the inside of the stomach and thus can eliminate the need for anysurgical or laparoscopic intervention. After one or more plications isformed, medical devices (including, but not limited to any of the typeslisted above) may be coupled to the plication(s) for retention withinthe stomach.

Certain of the disclosed plicators pass a mesh element and/or a quantityof sclerosing agent through the stomach wall such that it is disposedbetween the opposed regions of serosal tissue thus enhancing serosalbonding. Some embodiments include a feature that forms a hole in aplication using the plication device, so that a portion of a medicalimplant may be passed through or linked to the hole the plications.Others of the embodiments are configured to couple an anchor to theplication as it is formed, so that a medical implant may later becoupled to the anchor.

While this application describes plication systems and methods withrespect to the formation of plications in stomach tissue, theembodiments described herein have equal applicability for formingplications in parts of the body outside the GI system.

Plication System of the First Preferred Embodiment

FIG. 6 illustrates one embodiment of a system 10 for tissue plicationthat is suitable for endoscopic use, as well as surgical or laparoscopicuse if desired.

Generally speaking, system 10 includes a plicator 12 having a vacuumhead 14 and a shaft 16. The system further includes a flexible anchor 18for attachment to stomach tissue, a tissue penetrating tip element 20having a cable 22, a mesh element 24, and a sheath 26.

Referring to FIG. 7, vacuum head 14 defines a vacuum chamber 28 havingan opening that, during use, is positioned into contact with stomachtissue so as to draw the tissue into the chamber 28. Vacuum head 14further includes slots 32, 34 sized to receive portions of the anchor 18as described below. The distal and proximal ends of the vacuum head 14include U-shaped openings 36, 38.

Referring once again to FIG. 6, shaft 16 is a flexible elongate memberextending from the proximal end of the vacuum head 14. Shaft 16 isequipped with pull-wires (not shown) and/or alternative means forarticulating the vacuum head 14 as needed for proper positioning withinthe stomach. Shaft 16 includes a distal portion 40 having a generallyU-shaped slot 42 corresponding to the U-shaped opening 38 in the vacuumhead. The proximal portion 46 of shaft 16 is tubular and includes atleast one lumen 48 extending its length.

A tubular cannula 50 extends through the shaft 16 as shown in FIG. 6.Cannula 50 is fluidly coupled to a source of negative pressure such as asyringe or vacuum pump. Application of suction to the cannula 50 createsa vacuum in the vacuum chamber as discussed in detail below. As mostclearly visible in FIGS. 8A and 8B, cannula 50 includes an annularflange 53 (FIGS. 8A and 8B) surrounding its distal end. A plurality ofproximally-oriented ratcheting elements 51 (FIG. 8B) are positionedwithin the lumen of cannula 50, adjacent to the cannula's distal end.

Anchor 18 includes a distal tab 52 and a proximal tab 54 on oppositeends of a central portion 56. Anchor 18 is a flexible element formed ofsilicone or other flexible, biocompatible material. Its propertiespermit it to be deformed into the orientation shown in FIG. 9 forinsertion into the vacuum head. More specifically, the anchor 18 ispositionable within the vacuum head 14 as shown in FIG. 12 with thedistal tab 52 disposed in distal slot 32 and the proximal tab 54 withinproximal slot 34.

As best seen in the cross-section view of FIG. 9, a catch 58 is seatedwithin a recess in the distal tab 52 of anchor 18. Catch 58 may beformed of a resilient material such as stainless steel, nitinol, orresilient polymer that has been over-molded using rubber. As willdescribed in detail below, catch 58 functions to engage a portion of thetip element 20 (FIG. 6) after it has been advanced through the tissueundergoing plication. In the illustrated embodiment, catch 58 includes acutout 60 proportioned to engage the tip 20, however any alternativeconfiguration for the cutout 60 and tip 20 that will permit engagementof the two is equally suitable. A rubber protrusion 62 is positioned onthe anchor 14 to receive the sharp tip of the tip element to preventinjury to surrounding tissue.

Referring again to FIG. 9, proximal tab 54 includes an opening 64 withinwhich a spring element 66 is positioned. Materials used for the springelement may be similar to those used for the catch 58. Spring elementfunctions to engage cable 22 to retain the anchor in position, and itshould be appreciated that alternative features that can perform thisfunction can instead be used. As best shown in FIG. 11A, a preferredspring element 66 includes a pair of tabs 68 that can be pushed to aslightly outward orientation (see FIG. 11B) when acted upon by a forceshown by arrow A in FIG. 9, but that will return to the closedorientation when the force is relieved. Tabs 60, in their closedorientation, define a central cutout 70.

It is appropriate to note that anchor 18 may take many alternate formswithout departing from the scope of the invention. For example, in onealternative embodiment shown in FIG. 13, anchor 18 a includes a loop 2of the type described in connection with FIGS. 2-5 coupled to its distalend.

Referring again to FIG. 6, tip element 20 includes a piercing elementthat is sufficiently sharp to penetrate abdominal wall tissue whensubjected to an appropriate amount of force. The tip element 20 may beformed of stainless steel or any other material suitable for thispurpose. A preferred tip element includes a collar 73 which defines arecess 72 between the distal edge of the collar and the proximal edge ofthe tip. Recess 72 is proportioned to seat within the cutout 60 (FIG.10) of the anchor's distal catch 58 when the tip element is passedthrough the cutout 60.

Cable 22 is coupled to the proximal portion of the tip element 20. Cable22 preferably includes a series of barbs 74, teeth, or other engagementelements. As will be described in connection with FIG. 19A, during usethe cable is engaged by spring element 66 which allows the cable toslide in a proximal direction but that prevents movement of the cable ina distal direction. In other words, the cable functions in a mannersimilar to a cable tie found in hardware stores.

As discussed, the system is preferably designed to pass material betweenthe serosal tissue layers so as to faciliate serosal tissue bonding. Thematerial may be a synthetic or non-synthetic mesh (formed of nitinol orother material), porous or non-porous material, slotted material, or anyother material through which adhesions will form or onto which tissuewill grow. Examples include, but are not limited to, polypropylene,materials sold under the trade names Goretex or Dacron, or tissue graftmaterial such as the Surgisis material sold by Wilson Cook Medical, Inc.The material may be treated with tissue-ingrowth promoting substancessuch as biologics.

The delivered material can be constructed into any shape orconfiguration that will achieve its purpose of promoting strong serosaladhesions. As illustrated in FIGS. 14A and 14B, a convenient form forthe delivered material is that of a mesh tube 24 designed such thatapplication of compressive forces between the proximal and distal endswill cause the mesh to take the form of a disk, or such that it willself-expand to a disk-like shape when released from a restrainedposition. Tubular caps 76 a, 76 b formed of a suitable polymericmaterial may be attached to the distal and proximal ends of the tube tominimize damage to the mesh during compression.

Exemplary Method of Using the First Preferred Embodiment

One method of using the system of FIG. 6 will next be described.

In preparation for use, tip 20, cable 22, mesh element 24, and sheath 26are assembled for insertion into cannula 50. Specifically, as shown inFIG. 15A, mesh tube 24 is threaded over cable 22 and positioned suchthat its distal cap 76 b abuts the collar 73 of tip 20. Sheath 26 ispositioned over the mesh tube 24 and advanced such that its distal endis also in contact with the collar 73.

Referring to FIG. 15B, the assembled tip, cable, mesh element and sheathare inserted into the cannula 50. Anchor 18 is seated within the vacuumchamber 28 as described above. The flange 53 of the cannula 50 ispositioned in sealing contact with the anchor 18. For example, theflange 53 may be inserted into the proximal opening 64 (FIG. 9) of theanchor so as to create an interference fit between the two. Adequatesealing is desirable to prevent loss of vacuum pressure from the vacuumchamber 28 during use.

Next, the assembled plicator 12 is passed into the stomach S via theesophagus as shown in FIG. 16A. An endoscope 80 is also passed into thestomach to provide visualization of the procedure. Although theendoscope 80 is shown as a separate component, the plicator 12 may bemodified to include an integrated endoscope.

Referring to FIG. 16B, the plicator 12 is advanced to a target locationat which a plication is to be formed. The plicator is manipulated usingpull wires or other steering elements to place vacuum chamber 28 againstthe stomach tissue. Suction is applied to the vacuum chamber 28 viacannula 50, thus drawing stomach tissue into the vacuum chamber asshown. Consequently, a pocket 100 forms in the tissue such that if thestomach were to be viewed from the outside a depression in the stomachwall would be visible. Suction is maintained to stabilize the tissuewithin the vacuum chamber. If additional stabilization of the tissue isdesired, the plicator 12 may be provided with a barbed stabilizationcuff 82 of the type shown in FIG. 17A. Cuff 82 includes a plurality ofbarbs 84 oriented to penetrate stomach tissue as shown in FIG. 17B whenthe tissue is drawn into the chamber 28, thus holding the proximalportion of the captured tissue in place during advancement of the tipmember 20 and mesh 24 element. Other stabilizing mechanisms mayalternatively be used in lieu of, or in addition to, the cuff and barbs.

At this point, the tissue is ready for advancement of the tip member 20through the tissue, as well as deployment of the mesh tube 24 into thepocket 100. Advancement of the tip and deployment of the mesh may beperformed in a single step, or they may be formed as a sequence ofsteps. For simultaneous advancement and deployment, sheath 26 isadvanced in a distal direction, thereby driving the tip 20 distallythrough the tissue walls 102 defining the pocket 100. If the forces offriction between the tubular mesh element 24 and the sheath 26 aresufficiently large, the advancing sheath carries the mesh tube 24 intothe pocket. Alternatively, a pushing mandrel 86 (shown in FIG. 17B) maybe advanced distally against the proximal cap 76 a of the mesh element24 to advance the mesh element 24 into the pocket 100. If separateadvancement of the tip member 20 and deployment of the mesh element 24is preferred, the tip member 20 is first driven in a distal direction bydistal movement of the sheath 26, and the mesh element is thenseparately pushed over the cable 22 using the mandrel 86.

Many alternative structures useful for separately or simultaneouslyapplying pushing forces to the tip element 20 and the mesh element 24are readily conceivable and may also be used.

Regardless of the mode of deployment, as the tip member 20 is advanced,its pointed distal end moves into contact with the spring element 66 onthe anchor 18, causing tabs 68 (FIGS. 9, 11A and 11B) to push distallyinto the position shown in FIG. 11B, and to then return to theirsubstantially planar orientation (FIG. 11B) once the tip member 20 hascleared the spring element 66. The tip element 20 then passes throughthe walls 102 of tissue and into engagement with the distal catch 58 ofthe anchor 18 (i.e. the edges of the cutout 60 seat within recess 72 ofthe tip element 20), thereby locking the tip element to the catch 58.The distal-most portion of the tip element 20 embeds within theprotrusion 62 of the anchor.

The cable 22 remains attached to the tip element 20 and thus extendsthrough the walls 102, through catch 58 and spring element 66, andthrough the cannula 50. The mesh tube 24 remains disposed around thecable 22. FIG. 18A is a cross-section view of the stomach illustratingthe arrangement of the components after the tip element 20 and mesh tube24 have been deployed. FIG. 18B shows the outside of the stomach at thisstage of the procedure.

The next series of steps are geared towards drawing the distal andproximal tabs 52, 54 of the anchor 18 towards one another, so as toenclose the mesh element 24 within the pocket 100. Referring to FIG.19A, the vacuum head 14 is moved in a lateral direction until itseparates from the anchor 18 and the pocket 100. (If a barbedstabilization cuff 82 of the type shown in FIG. 17A has been used toengage the tissue, the cuff is first rotated to “unscrew” its barbs fromthe tissue. This might be achieved, for example, using a rotatableelement (not show) that may be grasped and rotated by the user.) Vacuumhead 14 is then positioned against the anchor 18 and used to impart adistally-oriented force against the proximal side of the anchor 18. Atthe same time, traction is applied to cable 22 so as to impartproximally directed forces to the distal end of the anchor. Ratchetingelements 51 in the cannula 50 prevent the cable 22 from sliding distallyin the event that traction of the cable 22 is momentarily released.

The opposed forces between cable 22 and vacuum head 14 result incompression of the anchor 18 and the mesh tube 24 into the illustratedpositions. As the cable 22 tightened, the spring element 66 of theanchor sequentially engages barbs on the cable 22. Once tension on cable22 is released, the spring element 66 remains engaged with the adjacentbarb on the cable so as to retain the anchor in the compressed position.Finally, the cable 22 is clipped, and the plicator 12 is withdrawn fromthe body, leaving the anchor 18 and mesh positioned as shown in FIG.19B. The procedure may be repeated to form multiple plications ifneeded. Following formation of the plication(s), a medical implant maybe coupled to the anchor(s) 18 during the course of the same procedureor during a later procedure scheduled to permit sufficient formation ofadhesions between the serosal tissue layers 102 to support the implant.

It should be noted with reference to FIG. 20 that in an alternativemethod, the cannula 50 may remain coupled to the anchor 18 duringlateral movement of the vacuum head 14, causing the proximal portion 40of the shaft 16 to separate from the cannula 50. According to thisembodiment, the anchor 18 may be compressed by pressing the cannula 50downwardly against the anchor 18 while applying tension to the cable 22.Once the anchor has been secured as described with respect to FIGS. 19Aand 19B, the cannula 50 is detached from the anchor 18 and withdrawnfrom the body.

Alternatives to the First Embodiments

One alternative system illustrated in FIGS. 21A through 21C is similarto the first preferred embodiment, but differs in that the vacuum head14 e is formed of a compliant material such as silicone and alsofunctions as the anchoring device. During use of the vacuum head 14 e,suction is applied to draw tissue into the vacuum head, and a cable 22 e(or suture, etc) is passed through the compliant silicone material toform the tissue plication. If necessary, a removable rigid housing 98may be positioned around the vacuum head to prevent it from collapsingduring application of suction.

In another alternative system shown in FIGS. 22A through 22D, a flexiblevacuum paddle 110 is positionable into contact with stomach tissue. Inthis embodiment, paddle 110 also serves as the anchor that will remaincoupled to the tissue.

Paddle 110 includes an elongate tube 112 that extends through theesophagus and is connectable to a vacuum source 114 positioned outsidethe body. Paddle 110 is formed of silicone or other flexible materialsuitable for long term implantation. Loop 2 is integrally coupled to thepaddle. An elongate spine 116 is positionable against the paddle 110,and may include elements for temporarily engaging the paddle 110. Spine116 includes pull wires or other features that may be manipulated fromoutside the body to deflect it and the adjacent paddle 110 into nestedcurved positions as shown in FIG. 22B, thus creating a pocket 100 in thetissue. A tip 120 coupled to a cable 122 may be advanced through theelongate tube 112 such that it penetrates the tissue lining the pocket100 and advances into a portion of the paddle 110, where it is engagedby a catch (e.g. see catch 58 of FIG. 8A). A mesh element 124 may beadvanced over the cable 122 as shown in FIG. 22C, and the cable 122 maybe cinched to form the plication using techniques such as thosedescribed above, leaving the paddle 110 and loop 2 in place.

An alternative system illustrated in FIGS. 23A and 23B is similar to thesystem of the first embodiment of FIG. 6. Specifically, system 10 fincludes a vacuum head 14 f mounted at the distal end of a shaft 16 f ofsufficient length to permit the vacuum head 14 f to be positioned withinthe stomach while the proximal portion of the shaft 16 f remains outsidethe oral cavity. The vacuum head is coupled to a source of suction, suchas a syringe or vacuum pump.

A flexible anchor 18 f is seated within vacuum head 14 f prior to use,similar to the positioning of the anchor 18 of the first embodimentshown in FIG. 12. The anchor 18 f includes a distal tab 52 f and aproximal tab 54 f having corresponding openings longitudinally alignedwith the lumen 48 f of the shaft 16 f. The system differs from the firstembodiment in that the anchor 18 f further includes an elongate leg 22 fthat is coupled to the tabs 52 f, 54 f during assembly to form theanchor 18 f into a loop. Leg 22 f includes a tip 20 f and a catch 21 fpositioned to engage the distal tab 52 f and the proximal tab 54,respectively. The leg 22 f may be manufactured of a flexible polymericmaterial such as silicon, or it could be formed of a mesh, braid, stentinto which surrounding tissue will grow. However, the tip 20 f should becapable of penetrating stomach wall tissue.

Prior to use, the leg 22 f is positioned within the lumen 48 f of shaft16 f. During implantation of the anchor 18 f, serosal tissue is drawninto the vacuum head 14 f as shown in FIG. 23A. The leg 22 f is advancedthrough the tabs 52 f, 54 f, and the sections of stomach wall lyingbetween the tabs, using a push rod (not shown) or other pushingmechanism as described above. The tip 20 f engages with distal tab 52 fand the catch 21 a is restrained by proximal tab 54 f. The vacuum head14 f is subsequently removed, leaving the anchor and leg forming a loopsurrounding a portion of the stomach wall as shown in FIG. 23B.

Although the method of implanting the anchor 18 f may end with theanchor 18 f positioned as shown in FIG. 23B, it is preferable to bringsome of the serosal tissue surfaces surrounding pocket 100 into contactwith one another so as to trigger growth of serosal bonds between thecontacting tissues surfaces, as described before. Methods for cinchingthe tissue to form a serosal plication are described above and may bemodified for use with the FIGS. 23A-23B method. Alternatively, elongateregions of tissue on opposite sides of the leg 22 f may be brought intocontact with one another and clamped, stapled and or otherwise held incontact to turn the pocket 100 into a sealed serosal pocket 100 fsurrounding the leg 22 f and isolated from the sterile environmentoutside the stomach. For example, as shown in FIG. 24A, a jaw-typestapling instrument 92 having a vacuum housing 93 may be endoscopicallyintroduced into the stomach and positioned with the jaws 94 a, 94 bcontacting mucosal tissue on opposite sides of the leg 22 f. Thisinstrument may be separate from the instrument used to couple the anchor18 f to the tissue, or the instrument of FIG. 23A may be modified toinclude the stapler jaws 94 a, 94 b.

The jaws are clamped as shown in FIG. 24B to bring the serosal tissuesurfaces together, and staples are passed through the tissue using thejaws, enclosing the pocket 100 in the tissue and helping to retain theanchor using the re-shaped stomach tissue. After the instrument 92 isremoved from the stomach, the serosal tissue surfaces remain held incontact by one or more staple lines 95 (FIGS. 25A and 25B). The staplelines 95 seal the pocket 100 f and reduce the chance of infection byforming a barrier preventing gastric contents that might enter thepocket 100 f from moving into the extra-gastric space. Adhesions willthen form between the serosal tissue surfaces as described above. Tooptimize the strength of the adhesions, the leg 22 f may includeingrowth-promoting features. For example, leg 22 f may be configured tosupport macro-level ingrowth using a mesh design, or it may includemicro-ingrowth promoting features such as a porous surface. Leg 22 fmight alternatively or additional have a surface coated or impregnatedwith sclerosing agents. Multiple anchors 18 f may be implanted usingthis method, as shown in FIG. 25C.

In alternate plication methods, one or more sclerosing agents may beused in conjunction with or in lieu of the mesh element 24. Examples ofsclerosing agents include but are not limited to Sodium TetradecylSulfate (STS), Poliodocanol, Chromated Glycerin, Hypertonic saline,Sodium Morrhuate, Sclerodex (hypertonic saline in combination withDextrose). Other substances that may be positioned with or in place ofthe mesh element 24 include methylmethacrylate, glues, adhesives, andbiorubbers. These may be injected at the time of mesh placement orloaded into the mesh itself and eluded out over a period of time.

FIGS. 26A through 26F illustrates an alternative method in which acannula 50 a having a tissue-penetrating distal end is passed into thetissue pocket 100 for delivery of an agent. According to the alternativemethod, tissue pocket 100 is formed using methods similar to thosedescribed above. Cannula 50 a is advanced through the shaft 16 a of theplicator 12 a, through anchor 18 a and tissue 102, and into the pocket100. The desired agent is passed through the cannula 50 a and into thepocket.

Once the agent is administered, steps similar to those described abovemay be performed to form the plication and to attach anchor 18 a to theplication. Tip 20 a (FIG. 26B) is thus advanced through the cannula 50 a(or through a separate cannula introduced upon removal of the cannula)and advanced as described in connection with the first embodiment. If amesh element 24 a is to be introduced, it may be positioned around thecable 22 a as described previously. A pusher tube 86 a may be threadedover the cable 22 a, through the interior of the mesh tube 24 a, andinto contact with proximal cap 76 a on the mesh element 86 a. Slidingthe pusher tube 86 a distally drives the tip 20 a through the plicationand into engagement with a distal catch 58 a on the anchor, as alsoadvances the mesh element 24 a into the pocket 100. In a final sequenceof steps, the plication may be “cinched” using methods similar to thosedescribed above.

In certain instances, it might be desirable to completely close theserosal pocket 100 to avoid leakage of injected agents into theperitoneal cavity. The pocket 100 may be sealed using an elongate clamp90 endoscopically introduced into the stomach and clamped over thetissue pocket to press the serosal surfaces into contact with oneanother as shown in FIGS. 27A and 27B. Alternatively, vacuum head 14 c(FIG. 28) may include clamping bars 92, such as elongate rods orinflatable balloons, that are positioned on opposite sides of the pocketto clamp the pocket 100 between them. As yet another alternative, thevacuum head 14 d may be biased or hinged to clamp the pocket 100 asshown in FIG. 29.

An alternative method for forming plications using sclerosing agents toaccelerate scar formation is illustrated in FIGS. 30A through 30E. Thismethod is advantageous in that it allows plications to be formed withoutthe use of sutures or cables, and thus can simplify the procedure.

As with previous methods, a pocket 100 or depression is formed on theserosal surface by drawing a portion of the stomach wall inwardly usinga vacuum head 14 f or other device introduced transorally into thestomach. A delivery member 130 is next introduced into the stomach. Thedelivery member 130 is an elongate tubular device having a lumen throughwhich a sclerosing agent may be delivered, as well as a delivery meansfor delivering a place holding element 132 into the pocket 100. Thedelivery member 130 preferably includes a sharpened distal tip capableof penetrating the stomach wall.

As shown in FIG. 30B, the delivery member 130 is advanced through atleast one portion of the stomach wall 102, and used to deliver the placeholding element 132 into the pocket 100. The place holding element 102functions to maintain separation between opposed serosal walls 102, sothat the volume between the walls can be filled by a sclerosing agentintroduced by the delivery member 130 or a separate delivery method.

In one embodiment, the place holding element 132 may be delivered bypushing it through the lumen of the delivery member using a pushingmandrel. The place holding element might be a section of material thathas a compact size and shape for delivery by the delivery member 130,but that expands upon delivery into the pocket 100. To give a fewexamples, the element may be formed of a structure having mechanicalproperties (e.g. sponge or nitinol mesh) that cause it to self-expandwhen released from the delivery member, or it may be an inflatableballoon tethered to an inflation lumen in the delivery member, or it maybe a swellable hydrogel that will increase in volume once exposed tofluid within the pocket (e.g. the sclerosing agent or other fluidinjected into the body, and/or fluids present in the peritoneal cavity).In alternate embodiments the place holding element might be delivereddirectly to the outside of the stomach using laparoscopic methods.

The element may be formed of a permanent or semi-permanent material(such as the examples described in connection with mesh element 24above), that will reinforce the plication and/or work together with thesclerosing agent to promote scar formation. Alternatively, the elementmay be one that is biodegradable or bioabsorbable over a period of time.

Once the place holding element 132 has been positioned, the vacuum head14 f or a separate clamping device is utilized to clamp and seal thepocket 100 as shown in FIG. 30C (see, for example, the sealing methodsdescribed above). Sclerosing agent is injected through the deliverymember 130 into the pocket 100. Referring to FIG. 31A, if the placeholding element is an inflatable balloon 132 a or another type ofelement that can seal against the tissue forming the pocket, it may beacceptable to eliminate the step of applying sealing forces to thepocket. Referring to FIG. 31B, use of a sponge 132 b in lieu of balloon132 a may minimize migration of sclerosing agent out of the cavity. Thesponge 132 b may be filled with sclerosing agent prior to its deliveryinto the pocket 100, or it may instead absorb agent introduced into thepocket.

Sealing forces continue to be applied to the pocket 100 until ample scartissue has formed within the pocket to maintain the P. Once adequatescar tissue has been formed, sealing forces may be released and thevacuum head removed from the stomach. If the balloon of FIG. 31A is usedin lieu of sealing forces, inflation of the balloon is maintained untilthe sclerosing agent has formed an adequate amount of scar tissue.

It should be noted with reference to FIGS. 32A and 32B that if sealingforces are needed over an extended during (i.e. to ensure sufficienttissue scarring to retain the plication), a clip 134 a may be clippedaround the plication to maintain the plication until sufficient scarringhas occurred. If needed to prevent unwanted detachment of the clip, analternative clip 134 b (FIG. 31B) may include prongs positioned to passthrough the tissue.

Plication System of the Second Preferred Embodiment

In many instances it may be desirable to form serosal tissue plicationsof the type shown in FIG. 33A, which include a cutout C or hole formedthrough the plication P. As shown in FIG. 33B, multiple such plicationsmay be formed within the stomach to provide a platform for mounting anintragastric device or for other purposes that will be described below.

When a cutout plication is formed, it may be beneficial to form a sealaround the cutout C using staples, sutures or adhesives etc so as toprevent food material and/or gastric juices from passing between theopposed layers of serosal tissue where they can potentially causeinfection between the tissue layers or within the extra gastric space.In the FIG. 33A example, a circular array of staples is placed in thetissue surrounding the cutout C for this purpose. Sealing the cutoutusing staples provides the additional benefit of controlling thebleeding that will occur along the edges of the cutout. In forming theplication P, reinforcing mesh or other suitable material may bepositioned between the opposed serosal layers so as to achieve thebenefits discussed in connection with the first embodiment.

A second preferred embodiment of a plication system 10 g, shown incross-section FIG. 34A, is particularly useful for forming a serosalplication having a cutout surrounded by a staple line, and also forpositioning a reinforcing mesh element within the plication.

In general, system 10 g includes a plicator 12 g comprising a vacuumhead 14 g having a vacuum chamber 28 g and a shaft 16 g defining a lumen48 g. A port 49 is fluidly coupled to the vacuum chamber 28 g and isconnectable to an extracorporeal source of suction (e.g. a syringe or avacuum pump).

An elongate staple driver 150 is longitudinally moveable within thelumen 48 g. Staple driver may take the form of an elongate tube having abroadened annular head 152 positioned within the vacuum head 14 g. Aplurality of staples 154 is arranged adjacent to the staple head,preferably in a circular arrangement, but alternative arrangements areequally suitable. A circular anvil 156 is positioned within the vacuumhead 14 g opposite the staples. Staple driver head 152 is moveable in adistal direction to advance the staples across the vacuum chamber andinto contact with the anvil 156.

The system includes a tubular cannula 50 g for forming the cutout C inthe tissue. Cannula 50 g extends through the lumen of the staple driver150, with its tissue-penetrating distal end oriented towards the vacuumchamber 28 g. Cannula 50 g may be advanced in a distal direction toextend through the vacuum chamber 28 g and into a tubular channel 158formed in the distalmost section of the vacuum head.

An elongate rod 160 having a pointed distal barb or tip 20 g extendsthrough the lumen of the cannula 50 g. Tubular mesh element 24 gsurrounds a portion of the exterior surface of rod 160, with its distalend adjacent to the proximal end of tip 20 g. Mesh element 24 g ispreferably a self-expandable tubular element of the type described inconnection with FIGS. 14A and 14B. When positioned on the rod 160, themesh element is compressed to a reduced-diameter position and retainedin the compressed position using a retention sleeve 162. A tubularsupport 164 may be positioned on the rod 160 in abutment with theproximal end of the mesh element 24 g.

System 10 g further includes a proximal handle (not shown) that remainsoutside the body during use of the system. The handle includesactuators, pull wires, push rods, or equivalent components thatfacilitate longitudinal advancement and withdrawal of the tip 20 g,cannula 50 g, retention sleeve 162, and staple driver 150, as well asdeflection or articulation of the components, as needed to carry out themethod for using the system described in the following section.

Exemplary Method for Using the Second Preferred Embodiment

A method for using the system of the second embodiment will next bedescribed. First, the vacuum head 14 g is introduced into a stomach andendoscopically positioned with the vacuum chamber facing the interiorsurface of the stomach wall. This step is similar to the stepillustrated in FIGS. 16A-16B in connection with the first embodiment.

Suction is applied to the vacuum head 14 g via port 49 to draw a portionof the stomach wall into the chamber as shown in FIG. 34B, thusorienting sections S1, S2 of the stomach wall with their serosalsurfaces generally facing one another.

Next, the rod 160 is advanced to drive tip 20 g through the sections S1,S2. Tip 20 g is captured within the channel 158 adjacent to anvil 156.The mesh element 24 g is carried by the rod 160 into position betweenthe stomach wall sections S1, S2. The retention sleeve 162 is retracted,allowing the mesh element 24 g to expand to the position shown in FIG.34D. One or more centering struts 166 extend between the mesh element 24g and rod 160 and maintain the mesh element in a generally centeredorientation relative to the rod 160.

After the mesh element 24 g is deployed, the tissue is compressed to theposition shown in FIG. 34E to bring the opposed sections S1, S2 of thestomach wall into contact or close proximity with one another and tocompress the mesh element 24 g into a disk shape (also see FIG. 14B).This folding/compressing step may be accomplished by folding the vacuumchamber 14 g itself, such as by pushing the shaft 16 g in a distaldirection while maintaining traction on the rod 160. After folding, thestaple driver head 152 is pushed distally, driving the staples 154through the tissue and against the anvil 156 as shown in FIG. 34F. In asimultaneous or separate step illustrated in FIG. 34G, the cannula 50 gis advanced to core the tissue, thus forming the cutout C and snippingthe centering struts 166 (not visible in FIG. 34G) connecting the meshelement to the rod 160. In forming the cutout C, the cannula 50 gremoves a margin of tissue surrounding the punctures created by tip 20 gduring its advancement towards channel 158.

The cannula 50 g and tip 20 g are withdrawn into shaft 16 f, and thevacuum head 14 g is separated from the tissue, leaving the cutoutreinforced plication as shown in FIGS. 35A and 35B.

Plication System of the Third Preferred Embodiment

A third embodiment of a plicator 200 is shown in FIGS. 36A through 39.Plicator 200 includes a plication head 202 positioned on the distal endof an elongate shaft 204. As with prior embodiments, shaft 204 is ofsufficient length to allow passage of the plication head 202 through themouth and esophagus into the stomach, while the proximal end of theshaft remains outside the body. A vacuum source 206 is fluidly coupledto the proximal end of the shaft 202. Pullwires 208 extend through theshaft 204 from a handle (not shown) in the proximal end of the shaft andare anchored to a more distal location within the shaft 204, so thatmanipulation of the pullwires by a user allows for steering/deflectionof the plication head 202. Shaft 204 may be formed of a plurality ofspine members that articulate relative to one another but that may belocked in a desired position to fix the spine a desired shape.

Plication head 202 includes a tapered, atraumatic, distal tip 210 and aproximal portion 212 coupled to one another by one, two or more hingemember 214. In the FIGS. 36A-39 embodiment, three hinge members 214 areshown. Each of the illustrated hinge members includes distal andproximal hinge plates 216 a, 216 b joined together at central hinge 218.The hinge members 214 are moveable between the generally elongatedposition shown in FIG. 36A, and to the expanded position of FIG. 36B inwhich the central hinge 218 extends outwardly and in which the distanceseparating distal tip 210 and proximal end 212 of the plication head isdecreased. As shown as a transparent element in the bottom plan view ofFIG. 38A and the end view of FIG. 38B, a membrane or shroud 215 coversthe hinge members 214 and is connected to the distal tip 210 andproximal portion 212 of the plication head 202 to form a vacuum chamber217. An opening 219 in the shroud positionable in contact with stomachwall tissue to allow tissue to be drawn into the chamber during use.Shroud 215 is preferably formed of silicone, elastomeric material, orany other inelastic or elastic flexible or deformable biocompatiblematerial capable of forming a vacuum chamber.

Referring to FIG. 37A, the proximal portion 212 of the plication head202 includes a hydraulic chamber 220. The hydraulic chamber 220 isfluidly coupled by a fluid line 222 to a source of fluid 224. An outerpiston 226 is disposed within the hydraulic chamber 220. In theillustrated embodiment, piston 226 is a hollow cylinder having a rearwall 228 and a front wall 230. Front wall 230 includes a center cutout232. An inner piston 234 is disposed within the outer piston 226, andincludes a longitudinal plunger 236 extending through the cutout 232.

Each of the proximal hinge plates 216 b includes an inwardly-extendingcamming surface 238. The hinge plates include proximal pivots 240 suchthat distally-oriented pressure against camming surfaces 238 causes thehinge plates 216 b to pivot about the pivots 240 into the position shownin FIG. 37B.

Proximal portion 212 of the plication head 202 includes a staplecartridge 242 containing staples arranged in an annular arrangement (notvisible in the drawing), and a staple driver 244 positioned to drivestaples from the distal end of the cartridge 242 when it is advanced ina distal direction into contact with the staples. Staple driver 244 mayinclude a tissue penetrating element 248 (FIG. 40B) sufficiently sharpto form a hole in tissue.

An anvil 246 on the distal tip 210 is positioned to receive the prongsof staples driven by staple driver 242 and to fold the prongs into aclosed position. Staple cartridge and anvil arrangements are well knownin the surgical and endoscopic stapling art and need not be discussed infurther detail. The staples (and sutures) described for use herein maybe permanent or bioerodible/biodegradable.

Exemplary Method for Using the Third Preferred Embodiment

As with the previously discussed methods, a method of using theplication system 200 of the third embodiment is carried out undervisualization using an endoscope advanced via the esophagus into thestomach.

In preparation for use, the plication head is positioned with the hingemembers 214 in the streamlined position shown in FIGS. 36A and 37A. Theplication head 202 is introduced transorally into the stomach, throughan introducer sheath if needed to ensure smooth passage through theesophagus. Pullwires 208 are manipulated to orient the plication head202 so that the opening 219 in the vacuum chamber 217 (FIGS. 38 and 39)is positioned in contact with stomach wall tissue at a location at whicha plication is to be formed.

Next, as shown in FIG. 37B, hydraulic fluid is injected from fluidsource 224 into chamber 220. The fluid pressure advances outer piston226 in a distally direction, causing the front wall 230 of the piston226 to contact the camming surfaces 238, thus pivoting the pivot plates216 b about proximal pivots 240. In response, hinge members 214 pivot asshown in FIG. 37B until they reach the partially expanded position shownin FIG. 37B. The vacuum source 206 is activated to create a vacuum whichdraws a pinch of tissue into the vacuum chamber 217, with serosal tissuesurfaces generally facing one another as has been described with theother embodiments (see e.g. FIG. 34B). The flexible nature of the shroudforming the vacuum chamber 217 allows the vacuum chamber 217 to deformoutwardly as tissue is drawn into the chamber.

Once tissue is drawn in to the vacuum chamber 217, additional fluid isdirected into the hydraulic chamber 220 to advance the outer piston 226until the hinge members 214 are in the fully expanded position shown inFIG. 37C. Expansion of the hinge members 214 draws the distal tip 210towards the proximal portion 212 of the plication head 202. Thiscompresses the tissue within the vacuum chamber 217, bringing theopposed serosal tissue surfaces into contact or close proximity witheach other similar to the tissue positions shown in FIG. 34E. Once thetissue is compressed, staples from the cartridge 242 are fired throughthe tissue by passing the staple pusher 244 through the staple cartridge242. If the staple pusher 244 is provided with a tissue penetratingelement 248 as shown in FIG. 40B, the tissue penetrating element 248penetrates the opposed layers of stomach wall tissue as the staples aredriven through the tissue, forming a hole surrounded by an annularpattern of staples.

The staples fold against the anvil 246. After stapling, the hingemembers are moved to the collapsed position shown in FIG. 36A. Theplicator is separated from the tissue and withdrawn from the body. Thetapered profile of the proximal portion 212 of the plication head 202allows the plication head 202 to pass through the gastro-esophagealjunction, esophagus, and mouth with minimal trauma.

In the illustrated embodiment, the staple pusher 244 is driven by theinjection of hydraulic fluid into the cylindrical piston 226. The fluiddrives plunger 236 distally into contact with the staple pusher 244,which in turns drives through the cartridge 242 to advance the staples.FIG. 40A illustrates one arrangement of the pistons 226, 234 within thehydraulic chamber 220 that will allow this to be achieved. As shown,hydraulic cylinder 220 includes first and second inlets I1 and I2, andthe piston 226 includes a third inlet 13. O-ring seals O1, O2 arepositioned on the exterior surface of piston 226 and o-ring seals O3 andO4 are positioned on the exterior surface of the inner piston 234. Whenhydraulic pressure is applied to I1, the piston 226 advances distally(towards the left in the view shown) to expand the hinge members 214(FIG. 37C) and compress the tissue as discussed above. After o-ring sealO2 has moved distally of inlet I2, fluid pressure can be directedthrough I2 and into I3, causing inner piston 234 to be driven distallyto advance the staple pusher 244 (FIG. 37A). Although in the FIG. 40Aembodiment the hydraulics for tissue compression and stapling andcombined on the proximal side of the plication head, these functions maybe separated, with the hydraulics driving one function positioneddistally of the vacuum chamber and the hydraulics driving the otherfunction positioned proximally of the vacuum chamber.

FIGS. 41A and 41B are side elevation views of a modified plication head202 c in which the distal and proximal portions 210 c, 212 c are coupledby a hinge 214 c that is actuated by a lead screw 211. Lead screw isextended as shown in FIG. 41A to elongate the plication head 202 c forpassage into the body and for expansion of the vacuum chamber which, aswith the FIG. 36A embodiment, is defined by a shroud 215 (FIG. 41C).Once tissue is drawn into the chamber, the lead screw 211 is actuated tobring the distal and proximal portions 210 c, 212 c into alignment forcompression and stapling of the tissue as described above.

Plication Reinforcements

Reinforcements of various types may be implanted in or on plicationsformed using the plication system. Such reinforcements may function toreinforce the staple array, help to more evenly distribute the forcesapplied to the tissue by the staples, and/or facilitate bonding betweenthe opposed serosal layers. Suitable reinforcements include onespositionable on or between the serosal tissue layers (“serosal sidereinforcements”), as well as those delivered on the side of the mucosaltissue (“mucosal side reinforcements”).

Serosal side reinforcements have been discussed in connection with thefirst and second embodiments. A reinforcement similar to mesh element 24described in connection with FIGS. 14A, 14B may serve as a permanent orsemi-permanent implant that will reinforce the staple array applied tothe tissue and/or facilitate serosal tissue bonding between the layersof stomach wall tissue that are to be stapled or sutured together. Forthis purpose, the material may be a synthetic or non-synthetic mesh(formed of nitinol, polyester, or other natural or synthetic material),porous or non-porous material, slotted material, or any other materialthrough which adhesions will form or onto which tissue will grow.Examples include, but are not limited to, polypropylene, materials soldunder the trade names Goretex or Dacron, or tissue graft material suchas the Surgisis material sold by Wilson Cook Medical, Inc. The materialmay be treated with tissue-ingrowth promoting substances such asbiologics.

In an alternative embodiment of a serosal side reinforcement shown inFIGS. 42A and 42B, a reinforcement 270 (which may be formed of apolyester fabric, mesh, or any other material including those listedelsewhere in this application) is carried by a frame 272 having aplurality of outwardly extending arms that spring to an expandedposition when released from a hollow tube. The tube might be any of thetubes described above for delivering mesh or sclerosing agents etc. tothe serosal tissue, e.g. tube 50 g of FIG. 34A. The hollow tube 274 ispassed through stomach wall tissue so that its distal end is positionedbetween serosal layers (e.g., the position of needle 50 a in FIG. 26B).The frame 272 is advanced out the distal end of the needle to allow thearms of the frame to spread to the expanded position shown, therebyexpanding the reinforcement between the opposed serosal layers. Thereinforcement is fixed between the layers by the staples driven throughthe opposed regions of stomach wall, and the frame is withdrawn from theneedle and out of the body.

Mucosal side reinforcements may take the form of reinforcements that arepositioned on or adjacent to one or both of the mucosal surfaces liningthe “pinch” of tissue that will form the plication. These reinforcementsmay be features of the staples or staple arrays, or they may be separatecomponents engaged by staples as the staples are advanced through thetissue.

Referring to FIG. 43A, conventional stapling procedures will ofteninclude two parallel rows of staples, in which the staples in one roware laterally offset from the staples of the other row. According to thedisclosed method, it is useful to employ this technique to the circularstaple pattern delivered using the plicators described above, to producetwo concentric rings of offset staples 276, as shown in FIG. 43B. It hasbeen found to be additionally beneficial to form mucosal sidereinforcements by linking or interlocking the staples to provide greaterstructural reinforcement to the stapled tissue and/or to more evenlydistribute forces applied to the tissue by the staples. Linked staplearrays may be formed by arranging the staples 276 in the cartridge ofthe plicator in a single circular pattern to interlock as shown in FIG.43C, or in a double circular pattern with two concentric rings ofinterlocked staples. The staples 276 a may be curvilinear so as to forma locking pattern shown in perspective view of FIG. 43D. A lineararrangement of staples 276 may also be linked as shown in FIG. 43E.

In alternative embodiments, staples are linked together by reinforcingmembers formed of metallic or polymeric materials, such as nitinol,titanium, stainless steel PEEK, or other biocompatible materialsincluding those that are bioerodible/biodegradable. According to theseembodiments, the reinforcing members are positioned on one or both ofthe mucosal sides of the “pinch” of tissue engaged by the plicationsystem such that they are captured by staples being driven through thetissue. In a preferred embodiment, the staples capture a cartridge sidereinforcing ring 278 (FIG. 13A) as they leave the cartridge and capturean anvil side reinforcing ring 280 (FIG. 44B) as the anvil shapes andbends them. Upon completion of the plication, the staples are linked toone another so that they cannot separate or expand radially. The ringspromote even distribution of forces around the ring of staples.

The reinforcing rings are preferably provided separate from the staplesalthough they instead may be integral with the staples. In theillustrated embodiment, ring 280 is positioned against the staple anvil246 as shown in FIG. 45A. Ring 278 is seated within the cartridge 242(FIG. 45B), with the staples 276 aligned with their prongs 282 extendingthrough a plurality of the loops 284 in the ring 278. When staples 276are driven from the cartridge, they capture ring 278 against theadjacent mucosal tissue as shown in FIG. 46A. The staple legs/prongs 282pass through the stomach wall tissue into contact with the indentations286 of the anvil 246. When they contact the anvil 246, the prongs 282fold around the staple ring 280 to capture the ring 280 and interlockthe staples on the anvil side of the plication as shown in FIG. 46B.Rings or other interlocking elements of this type may be used withsingle- or double-staple row configurations.

Rings 278, 280 are shown as generally circular, although alternativereinforcements of different shapes and patterns may also be used,including those shaped to accommodate linear, oval and other staplepatterns.

Applications for Cutout Plications

FIGS. 47A through 49 illustrate examples of applications for cutoutplications formed within the stomach using any methods or system,including those described above. As shown, the cutout plications caneliminate the need for anchor loops of the type described in connectionwith the first embodiment. Each of these applications is preferably (butoptionally) performed in a separate procedure from that in which theplications are formed, so as to allow serosal bonding to occur beforethe plicated tissue is subjected to stresses imparted by implants and/orfurther manipulation.

A first application shown in FIGS. 47A through 47C uses two or morecutout plications CP, preferably formed at the gastro-esophagealjunction region of the stomach. According to this application, thecutouts C of the plications are brought into partial or full alignmentwith one another (FIGS. 47A and 47B) using an endoscope or anotherendoscopic instrument. A restrictive implant such as the implant 4 shownin FIG. 4 is threaded through the aligned cutouts while in aradially-collapsed position, and is then allowed to expand to theposition shown in FIG. 47C. Instruments and methods for orienting andexpanding an implant of this type are shown and described in U.S.application Ser. No. 11/439,461, filed May 23, 2006. Once in place, theimplant greatly reduces the amount of food a patient can consume, byslowing the rate at which food can descend from the esophagus into thestomach.

In the method shown in FIG. 48A, multiple cutout plications CP areformed in select positions allowing the plications to be drawn togetherso as to significantly narrow the channel through which food can passthrough the stomach. For example, the plications CP of FIG. 48A arearranged such that manipulating the plications to place their cutouts Cin alignment causes the plications themselves to form a barrier againstpassage of food. This arrangement limits most food flow to a narrow foodpassage FP and creates a gastric pouch GP adjacent to the food passage.An implant 4 a is positioned within the cutouts C as described above toretain the plications CP in their gathered arrangement. The implant 4 amay have a similar configuration to the implant 4 of FIG. 4, including athrough-hole allowing some passage of food through the implant, or itmay be impenetrable by food thus forming a plug largely preventingpassage of food and gastric juices through the cutouts C. The implantmay include a valve oriented to minimize restriction of food flow out ofthe stomach during vomiting. Other implants that will retain thegathered configuration of the plications CP may alternatively be used,including lengths of biocompatible material passed through the cutoutsand knotted or otherwise fastened into loops. In other embodiments, thecollective sizes and numbers of the plications may themselves besufficient to restrict flow of food into the stomach, without the needfor any implants to connect them to one another.

In either embodiment, if the implant 4, 4 a is to be removed or replacedwith an implant of different dimensions (e.g. so as to slow the rate ofweight loss following a period of significant weight loss, or toincrease the rate of weight loss), endoscopic instruments may be used towithdraw the implant from the cutouts C and to remove the implant fromthe stomach.

In another embodiment shown in FIG. 49, a restrictive pouch 4 b mayinclude anchors 5 that are inserted into cutout plications CP. Anchors 5are shown as having a button shape, but they may alternatively be otherstructures including loops that close on themselves to preventdetachment from the cutout, or they might be legs of the type disclosedin WO 2005/037152.

As is evident from above, the disclosed endoscopic systems function todraw a tissue into the stomach to form a depression on the exteriorsurface of the stomach, and staple (or suture, or fasten or adhere etc)the opposed stomach wall sections lining the depression together anotherto form a plication. The system may additionally place material of atype that will promote strong tissue adhesion within the depression (onthe exterior of the stomach) and retain the material between the serosalsurfaces to enhance. Additionally or alternatively, mucosalreinforcements such as structures that interconnect the staples may beimplanted. While these systems provide convenient embodiments forcarrying out this function, there are many other widely varyinginstruments or systems may alternatively be used within the scope of thepresent invention. Moreover, the disclosed embodiments may be combinedwith one another in varying ways to produce additional embodiments.Thus, the embodiments described herein should be treated asrepresentative examples of systems useful for forming endoscopic tissueplications, and should not be used to limit the scope of the claimedinvention.

Any and all patents, patent applications and printed publicationsreferred to above, including those relied upon for purposes of priority,are incorporated herein by reference.

We claim:
 1. An endoscopic stapler for fastening tissue, comprising: afastening head including: (i) a first portion including a staplecartridge with one or more staples therein; (ii) a second portionincluding an anvil; (iii) at least one hinge member connecting the firstportion and the second portion for movement toward and away from oneanother along an axis extending through the first portion and the secondportion, wherein each hinge member of said at least one hinge memberincludes first and second sections that are mounted on said first andsecond portions, respectively; and (iv) a flexible membrane extendingbetween the first portion and the second portion to define a tissuecapture region therebetween, wherein the at least one hinge member isconfigured such that movement of the first portion and the secondportion toward one another to staple tissue positioned in the tissuecapture region corresponds to movement of the first and second sectionsof each hinge member outwardly away from said axis to enlarge the tissuecapture region in a direction orthogonal to said axis.
 2. The stapler ofclaim 1, wherein the at least one hinge member includes three hingemembers connecting the first and second portions.
 3. The stapler ofclaim 1, wherein the flexible membrane extends over the at least onehinge member, said flexible membrane including an opening through whichtissue can be drawn into the tissue capture region when a vacuum isapplied.
 4. The stapler of claim 1, for use in fastening a tissue foldto make a tissue plication, wherein tissue in the tissue capture regionforms a tissue fold.
 5. The stapler of claim 1, wherein the staplecartridge includes an annular array of staples.
 6. The stapler of claim1, wherein the first section and the second section of each hinge memberare connected together by a hinge.
 7. The stapler of claim 1, for use infastening tissue within a body cavity of organ, the stapler furtherincluding an elongate shaft having proximal and distal ends, where thefastening head is attached to the distal end of the shaft with a longaxis of the shaft aligned with the axis of movement of the two portionsof the fastening head.
 8. The stapler of claim 1, wherein the firstsection of each hinge member is pivotably coupled to the first portionof the fastening head and the second section of each hinge member ispivotably coupled to the second portion of the fastening head.
 9. Thestapler of claim 1, wherein the first portion of the fastening headincludes a needle, and the second portion of the fastening head includesa catch for engaging a portion of the needle.
 10. The stapler of claim1, further comprising a reinforcing element positioned between the firstand second portions such that the reinforcing element is adapted to besecured to the stapled tissue.
 11. The stapler of claim 10, wherein thereinforcing element is positioned in proximity to the anvil such that astaple passing through the tissue into contact with the anvil will foldaround the reinforcing element to secure the reinforcing element to thestapled tissue.
 12. The stapler of claim 1, further including a piercingelement extendable through tissue in the tissue capture region to form ahole in tissue layers stapled together by the fastening head.
 13. Thestapler of claim 12, wherein the piercing element is positioned to forma hole bounded by staples delivered by the fastening head.
 14. Thestapler of claim 1, further comprising a piston assembly coupled to thestaple cartridge for advancing the at least one staple from thecartridge.
 15. The stapler of claim 14, wherein the piston assemblycomprises at least one hydraulic chamber.
 16. The stapler of claim 1,wherein the flexible membrane is radially outside of the at least onehinge member.
 17. The stapler of claim 1, wherein the at least one hingemember includes a first material, and the flexible membrane includes asecond material different than the first material.